ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. No adverse reactions have been reported for Sodium Fluoride 18 Injection based on review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.. No adverse reactions have been reported for Sodium Fluoride 18 Injection based on review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems(6).To report SUSPECTED ADVERSE REACTIONS, contact 3D Imaging at 1-501-353-2883 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION SECTION.

11 DESCRIPTION. 11.1 Chemical Characteristics. Sodium Fluoride 18 Injection is positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[18F] with molecular weight of 40.99, and has the following chemical structure: Na+ F- Sodium Fluoride 18 Injection is provided as ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 10 mL multiple- dose glass vials or mL or 10 mL plastic syringes with variable total volume and total radioactivity in each vial.. 11.2 Physical Characteristics. Fluoride F18 decays by positron (+) emission and has half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of positron with maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Fluorine F18 atom decays to stable 18O-oxygen.Table 2: Principal Emission Data for Fluoride F18 Radiation/Emission% per DisintegrationMean EnergyPositron (+)96.73249.8 keVGamma (+-) 193.46511.0 keVThe specific gamma ray constant (point source air kerma coefficient) for fluoride F18 is 5.7 R/hr/mCi (1.35 10 -6 Gy/hr/kBq) at cm. The half-value layer (HVL) for the 511 keV photons is mm lead (Pb). range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide is shown in Table 3. For example, the interposition of an mm thickness of Pb with coefficient of attenuation of 0.25 will decrease the external radiation by 75%.Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) ShieldingShield Thickness (Pb) mmCoefficient of Attenuation00.0040.5080.25130.10260.01390.001520.0001Table lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.Table 4: Physical Decay Chart for Fluoride F18Time Since CalibrationFraction Remaining01.0015 minutes0.90930 minutes0.82660 minutes0.683110 minutes0.500220 minutes0.250440 minutes0.06012 hours0.01124 hours0.0001.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Multiple-dose vial or single-dose syringe containing 370-7,400 MBq/mL (10-200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride 18 Injection is clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.. Multiple-dose vial or single-dose syringe containing 370-7,400 MBq/mL (10-200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution(3). Sodium Fluoride 18 Injection is clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED. Sodium Fluoride 18 Injection is supplied in multiple-dose Type glass vial with (elastomeric) stopper and aluminum crimp seal, or plastic syringe with cap, containing between 370 and 7,400 MBq/mL (10-200 mCi/mL) of no carrier-added sodium fluoride F18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial or syringe are variable. Each vial or syringe is enclosed in shielded container of appropriate thickness.The product is availablein 10 mL vial or 5 or 10 mL plastic syringe configuration with variable fill volume. The NDC numbers are:76451-018-10 (10 mL vial)76451-018-11 (10 mL syringe)76451-018-51 5 mL syringe). Storage. Store at 25C (77F); excursions permitted to 15-30C (59-86F). Use the solution within 12 hours of the EOS reference time. Handling. Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package Inner and Outer Labels. Outer labels are exterior to the radiation shielding for the product vial and contain the direct labeling information. There is an inner label that can be printed and applied in advance to avoid radiation dose to the operators and is small enough to affix to the vial. The inner label contains the product name and batch number that positively connects it to the correct outer label. The outer label contains complete package label information and all dose information that is determined at the time of filling.. 10 mL Vial Outer Label. 10 mL Vial Outer 10 mL Vial Outer Label. 10 mL Syringe Outer Label. 10 mL Syringe Outer 10 mL Syringe Outer Label. mL Syringe Outer Label. mL Syringe Outer 5 mL Syringe Outer Label. Inner Label, All. Inner All. Inner Label, All.

SPL UNCLASSIFIED SECTION.

11.1 Chemical Characteristics. Sodium Fluoride 18 Injection is positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[18F] with molecular weight of 40.99, and has the following chemical structure: Na+ F- Sodium Fluoride 18 Injection is provided as ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 10 mL multiple- dose glass vials or mL or 10 mL plastic syringes with variable total volume and total radioactivity in each vial.